JJ Seeks US Approval for Caplyta in Bipolar Mania

Johnson and Johnson reports its drug Caplyta successfully eased manic symptoms in a second late stage study. The positive results support a planned US regulatory filing seeking approval for bipolar mania.

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A Johnson & Johnson banner is displayed on the front of the New York Stock Exchange (NYSE) in New York City, in New York City, U.S., December 5, 2023.  REUTERS/Brendan McDermid

Johnson & Johnson reported that Caplyta eased manic symptoms better than placebo in a second late-stage study, paving the way for a United States regulatory filing. The trial tested a 42 mg daily dose over three weeks in adults with bipolar I disorder. The results strengthen the drug's commercial outlook as the health care giant expands its neuroscience portfolio.